The purpose of this study is to determine the safety and activity of SGN-40 in a weekly dosage schedule as a single agent.
This is an open-label, multi-dose, single-arm, phase I, dose-escalation study to define the toxicity profile, maximum tolerated dose (MTD), pharmacokinetics, and antitumor activity of SGN-40 in patients with refractory or recurrent multiple myeloma. A minimum of three patients will be entered into each dose-level cohort. All patients will receive a dose-loading schedule during the first two weeks. The maximum weekly dose will be 16mg/kg.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
0.5-8 mg/kg IV (in the vein) on Day 1; 0-8 mg/kg on Day 4; 0.5-16 mg/kg on Days 8 and 15; 0-16 mg/kg on Day 29.
James R. Berenson M.D., Inc.
West Hollywood, California, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Cornell University
New York, New York, United States
Adverse events and lab abnormalities.
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The Cleveland Clinic
Cleveland, Ohio, United States